On Aug. 19, 2020, Quidel announced that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA had been amended to include either nasal or nasopharyngeal swabs.

The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits. Quidel’s Sofia® SARS Antigen FIA has always been authorized for use with either nasal or nasopharyngeal swabs specimens. Due to customer preference, the Sofia SARS Antigen kit has been sold only with a nasal swab. A new kit configuration including nasopharyngeal swabs allows Quidel to increase its weekly delivery of the Sofia Antigen test.

Quidel currently sells the Sofia® SARS Antigen FIA in the United States under Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.